Completed
PHASE1
INTERVENTIONAL
NCT05978713
A Study of Tirzepatide (LY3298176) in Healthy Lactating Females
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The main purpose of this study was to look if the study drug, tirzepatide, gets into the breastmilk and, if yes, how long it takes the body to get rid of it from the breastmilk. The study drug was given as a single injection under the skin in healthy lactating females. For each participant, the total duration of the study was approximately 8 weeks, including screening.
Interventions
Name:
Tirzepatide
Type:
DRUG
Description:
Administered SC
Primary Outcomes
Measure:
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide in Breastmilk From Zero to Infinity (AUC [0-∞])
TimeFrame:
Predose, 3, 6, 9, 12, 16, 24, 36, 48, 72, 96, 120, 168, 336, 504, 672 hours post-dose
Description:
PK: AUC (0-∞) of Tirzepatide excreted in Breastmilk
Trial Information
NCT ID
NCT05978713
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
Eli Lilly and Company
Last Updated
December 15, 2025